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Cisplatin and Irinotecan in Treating Patients With Locally Advanced or Metastatic Esophageal or Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00003055
Recruitment Status : Completed
First Posted : July 30, 2004
Last Update Posted : June 21, 2013
Information provided by:

November 1, 1999
July 30, 2004
June 21, 2013
June 1997
April 2001   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003055 on ClinicalTrials.gov Archive Site
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Cisplatin and Irinotecan in Treating Patients With Locally Advanced or Metastatic Esophageal or Gastric Cancer
Phase II Trial of Cisplatin and Irinotecan in Patients With Advanced Esophageal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with locally advanced or metastatic esophageal or gastric cancer.

OBJECTIVES: I. Evaluate the response rate of combined cisplatin and irinotecan in patients with metastatic or locally advanced (inoperable or recurrent) esophageal or gastric cancer. II. Evaluate the toxic effects both qualitatively and quantitatively of cisplatin and irinotecan in these patients. III. Estimate the disease free and overall survival of these patients. IV. Assess whether the response proportion differs between squamous cell and adenocarcinoma of the esophagus. V. Evaluate quality of life issues using the Memorial Symptom Assessment Scale, the FACT-G questionnaire, and the dysphagia scale.

OUTLINE: Patients receive cisplatin and irinotecan on days 1, 8, 15, and 22 for 4 weeks, followed by a 2 week rest period. Each treatment course lasts 6 weeks. Patients receive at least 3 courses of therapy if the treatment is well tolerated and no disease progression is documented. Patients attaining a complete response receive additional courses of therapy at the discretion of the investigator. Tumor status is reassessed at 6 weeks and every 12 weeks thereafter. Patients are followed until death.

PROJECTED ACCRUAL: A total of 28-50 patients will be accrued within 12-18 months. Accrual for adenocarcinoma of the esophagus is complete.

Phase 2
Primary Purpose: Treatment
  • Esophageal Cancer
  • Gastric Cancer
  • Drug: cisplatin
  • Drug: irinotecan hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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April 2001
April 2001   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: Histologically proven locally advanced (surgically unresectable) or metastatic squamous cell of the esophagus or carcinoma of the stomach Patients with tumor extension below the GE junction into the proximal stomach must have the bulk of the tumor involve the esophagus or GE junction Bidimensionally measurable or evaluable disease No CNS metastases or carcinomatous meningitis No bone metastases (Closed to adenocarcinoma of the esophagus as of 05/1998)

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky 60-100% Life Expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 3 times upper limit of normal (ULN)(no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No unstable angina No New York Heart Association class III or IV cardiac disease Pulmonary: No interstitial pulmonary fibrosis Other: Not pregnant or nursing Negative pregnancy test No active or uncontrolled infection No prior malignancy for at least 5 years, except: Nonmelanoma skin cancer Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior radiation to the pelvis Surgery: Not specified

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000065703 ( Registry Identifier: PDQ (Physician Data Query) )
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Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: David H. Ilson, MD, PhD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP